1stOncology™: Cancer Intelligence Service – Page 927 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Verismo Therapeutics Presents Promising Preclinical Data at SITC 2025 for SynKIR™-110 in Solid Tumors

On November 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the presentation of new preclinical data from its lead clinical pipeline, SynKIR-110 to target mesothelin on solid tumors, at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting. The oral presentation showcased their latest preclinical data demonstrating SynKIR-110’s improved safety profile and enhanced anti-tumor activity compared to conventional CAR T therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The oral presentation, "A Novel NK-cell Based Split-Signaling Killer Immunoglobulin Receptor (KIR)-Based CAR T Targeting Mesothelin, SynKIR-110, Shows Increased Safety Profile and Increased Efficacy in vitro and in vivo" was delivered by Dr. Nora Yucel, Principal Scientist at Verismo Therapeutics.

Key Findings:

Enhanced Tumor-Specific Serial Killing: In vitro, SynKIR-110 showed sustained killing of MSLN-expressing tumor cells while minimizing off-target activation and cytokine release.
Reduced Exhaustion and Improved Functional Persistence: Unlike conventional 41BB-CD3ζ CAR T cells, SynKIR-110 exhibited reduced activation and exhaustion markers in vitro, suggesting less tonic signaling and functional exhaustion.
Improved Anti-Tumor Activity: In NSG mouse models of mesothelioma, SynKIR-110 induced deep and prolonged regression of implanted tumors and metastatic spread.
Less Off-tumor Activity: SynKIR-110 cells were selectively enriched in tumors and reduced in, normal tissues – contrasting with the off-tumor accumulation in lung and normal tissues observed with conventional 41BB-CD3ζ CAR T designs.
"Conventional CAR T therapies have faced significant safety and efficacy challenges in treating solid tumors," said Dr. Laura Johnson, CSO/COO of Verismo Therapeutics. "Our SynKIR platform presents a truly novel signaling platform approach designed to allow CAR T cells to rest and recover when not engaged with tumors, which in turn may reduce T cell exhaustion and improve safety and efficacy of tumor-specific killing."

SynKIR-110 is currently being evaluated in a Phase 1 clinical trial (NCT05568680) in patients with advanced ovarian cancer, cholangiocarcinoma, and mesothelioma, and has received both Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for the treatment of mesothelioma.

(Press release, Verismo Therapeutics, NOV 10, 2025, View Source [SID1234659744])

Tiumbio to Present First Clinical Data for Dual TGF-β/VEGF Inhibitor Tosposertib (TU2218) at SITC 2025, "Robust Response Rate"

On November 10, 2025 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 annual meeting, Tiumbio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company dedicated to developing novel therapies for rare and intractable diseases, reported the interim Phase II clinical data for its "first-in-class" Tosposertib (TU2218), a dual inhibitor against TGFβ type I receptor (TGFβRI /ALK5) and VEGFR2. The study evaluated Tosposertib in combination with MSD’s Keytruda (pembrolizumab) as a first-line therapy for patients with recurrent/metastatic(r/m) head and neck squamous cell carcinoma (HNSCC).

Tosposertib (TU2218) is a highly potent, oral dual inhibitor designed to block the signaling pathways of transforming growth factor-beta (TGF-β) and vascular endothelial growth factor (VEGF), two critical mediators of tumor growth and metastasis. This novel drug candidate was discovered and developed by Tiumbio to enhance the therapeutic efficacy of immune-oncology agents such as Keytruda.

Hun-Taek Kim, Ph.D., CEO of Tiumbio, stated "The data presented at SITC (Free SITC Whitepaper) mark an important milestone, demonstrating that the strong antitumor activity continues to be sustained with accumulating clinical data and ongoing follow-up." He added, "The combination of Tosposertib (TU2218) and Keytruda has shown meaningful potential and value as an immuno-oncology therapy capable of overcoming the limitations of existing immunotherapies or immunotherapy/chemotherapy combinations in recurrent or metastatic head and neck cancer."

The company plans to actively advance patient enrollment for the Tosposertib combination therapy and expand its global clinical trial sites to accelerate the studies required for regulatory approval. Through these efforts, the company aims to provide patients with recurrent or metastatic head and neck cancer earlier access to treatment and, in collaboration with global partners, continue to pursue combination trials and broader indication expansion.

Tosposertib (TU2218: TGF-β/VEGF dual inhibitor): Solid Tumors

Poster title: Phase 2 trial of TU2218, TGFβ-RI and VEGF-R2 dual inhibitor in combination with Pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC)

Observations in the poster presentation include:

As of July 31, 2025 data cutoff date, 27 patients (pts) were enrolled
The efficacy-evaluable population consisted of 17 patients who had received prior treatments such as surgery, chemotherapy, or radiotherapy.
Response rates overall (N=17): 70.6%, including 9 confirmed partial responses (PRs) and 3 unconfirmed PRs by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including
1L : Response rates overall (N=11) : 72.7% (8/11), including 6 confirmed partial responses (PRs) and 2 unconfirmed PRs
2L+ : Response rates overall (N=6) : 66.7% (4/6), including 3 confirmed partial response (PRs) and 1 unconfirmed PRs
Responses observed across PD-L1 levels (CPS 1-19: 66.7% [8/12]; CPS≥20: 80% [4/5])
At the time of data cutoff, 17 patients of the 27 enrolled, remained on treatment.
Median follow up of 2.6 months for the 27 patients
In 27 patients the combination was well tolerated and no significant overlapping toxicities with pembrolizumab were observed.
Treatment-emergent adverse events (TEAEs) were reported in 26 pts
Most were Grade (G) 1 or 2 in severity (no G5 were observed)
G≥3 TEAEs occurred in 11 patients (40.7%)
Most common adverse events included rash and mucositis.
No cases of major bleeding or cardiovascular toxicities-safety concerns typically associated with VEGF or TGF-β inhibition- were observed

(Press release, TiumBio, NOV 10, 2025, View Source [SID1234659743])

Servier’s Clinical and Real-World Data at 2025 SNO Congress Showcase Leadership in IDH-Mutant Glioma

On November 10, 2025 Servier reported that it will present new and updated data from its neuro-oncology program at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19 – 23 in Honolulu, Hawaii. Presentations will demonstrate progress across Servier’s neuro-oncology portfolio, highlighting clinical and real-world evidence in isocitrate dehydrogenase (IDH) mutant glioma.

Notably, Servier will present an analysis from the Phase 3 INDIGO trial comparing volumetric (3D) and traditional bidirectional (2D) assessment in patients with Grade 2 IDH-mutant glioma receiving VORANIGO or placebo in an oral presentation on November 22. The findings show that 3D assessments may provide a more clinically meaningful determination of progression in Grade 2 glioma trials, potentially impacting future trial design and endpoint selection.

In addition, Servier will also share results from the Phase 1b part of an ongoing Phase 1b/2 study evaluating VORANIGO in combination with temozolomide in patients with newly diagnosed Grade 4 IDH mutant astrocytoma on November 22. These data represent the first published data evaluating the safety of combining an IDH inhibitor with current standard of care chemotherapy in higher grade IDH mutant gliomas.

"As a pioneer in targeted therapies for brain tumors, Servier – working with the neuro-oncology community – is using our unmatched clinical trial datasets to better understand how these medicines affect tumor growth," said Islam Hassan, Global Head of Development-Neuro-Oncology & Senior Director, LS/LCM at Servier. "The critical insights presented at SNO will enable efficient clinical trial designs across all IDH-mutant glioma grades, including in combination with temozolomide in higher grade settings, to help us deliver potential new treatment options faster to patients who are eagerly awaiting them, all while upholding the highest level of evidence."

(Press release, Servier, NOV 10, 2025, View Source [SID1234659742])

Insilico and Lilly Enter a Research & Licensing Collaboration to Advance AI-Driven Drug Discovery

On November 10, 2025 Insilico Medicine ("Insilico"), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, reported a research collaboration with Eli Lilly ("Lilly") that the two parties will combine Insilico’s state-of-the-art Pharma.AI platforms with Lilly’s development and disease expertise to jointly discover and advance innovative therapies.

Insilico will utilize its validated Pharma.AI platform and deep drug discovery expertise to generate, design, and optimize candidate compounds against targets defined under the agreement. Insilico is eligible to receive over $100 million including an upfront, milestone payments, and tiered royalties on net sales upon commercialization of any resulting drug products.

"We are delighted to collaborate with Lilly, a global leader in the pharmaceutical industry, renowned for its commitment to medical innovation," said Alex Zhavoronkov, PhD, Founder and Co-CEO of Insilico Medicine. "Lilly has been a valued user of our Pharma.AI software suite, and this expanded collaboration further recognizes Insilico’s AI-driven drug discovery capabilities while strengthening our longstanding partnership. By joining forces, we are accelerating the development of transformative therapies to address urgent patient needs worldwide."

The collaboration represents a further deepening of the partnership between the two companies, which originated with the AI-based software licensing agreement in 2023.

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development. While traditional early-stage drug discovery typically requires 3 to 6 years, from 2021 to 2024 Insilico nominated 20 preclinical candidates, achieving an average turnaround – from project initiation to preclinical candidate (PCC) nomination – of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, NOV 10, 2025, View Source;licensing-collaboration-to-advance-ai-driven-drug-discovery-302610234.html [SID1234659741])

Geneseeq Receives NMPA Approval for PanTRKare™ – China’s First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions

On November 10, 2025 Geneseeq Technology Inc., a global precision oncology company, reported its PanTRKareNTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit has received marketing authorization from China’s National Medical Products Administration (NMPA). The assay is approved as a companion diagnostic (CDx) test for Roche’s ROZLYTREK (entrectinib). This milestone marks China’s first next-generation sequencing (NGS)-based pan-solid tumor NGS CDx test, and it is also the first approved assay for detecting NTRK1/2/3 gene fusions.

Addressing Unmet Clinical Needs: Shedding Light on Rare Mutations

NTRK gene family fusions occur in less than 1% of all solid tumors, but represent one of the most actionable oncogenic alterations across cancer types. Patients harboring these fusions can benefit from TRK inhibitors such as ROZLYTREK. PanTRKare enables accurate, sensitive detection of NTRK1/2/3 fusions across diverse tumor types, bringing precision medicine to patients who harbor this rare but important type of mutations.

Robust Clinical Validation Across 33 Tumor Types and 2,400+ Cases

The PanTRKare kit was rigorously validated through a large-scale multi-center clinical study involving seven leading hospitals, 33 tumor types and more than 2,400 clinical samples. The assay demonstrated high accuracy, sensitivity, reproducibility and broad applicability across a wide spectrum of solid tumors, having successfully detected more than 200 unique NTRK fusion variants in this study. This comprehensive validation establishes PanTRKare as one of the most clinically robust NTRK CDx test globally, ensuring confidence in both routine oncology and translational research settings.

Empowering Targeted Therapies Through Collaborative CDx Development

Clinical bridging studies with ROZLYTREK showed high concordance of testing results, as well as comparable objective response rate (ORR) among NTRK fusion–positive patients. This result underscores the test’s clinical utility and its pivotal role in advancing precision medicine for patients with rare genetic alterations.

"With the NMPA approval of PanTRKare, clinicians across China can now access an accurate, reliable tool to identify patients with NTRK gene fusions and connect them to effective targeted therapies. This milestone reflects Geneseeq’s ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics," said Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc.. "Geneseeq will continue to drive innovation across oncology diagnostics through global regulatory collaborations, biopharma partnerships, and patient-centered product development, advancing its mission to make precision medicine accessible to all."

(Press release, Geneseeq, NOV 10, 2025, View Source;chinas-first-ngs-based-pan-solid-tumor-companion-diagnostic-kit-for-ntrk-gene-fusions-302610192.html [SID1234659740])